ISO 9001 Notes

Sprinkled throughout the ISO 9001 standard are notes. These are highlighted by the word ‘NOTE’ in capitals. Examples of ISO 9001 notes are:

• In segment 4.1 "NOTE 1 Processes needed for the quality management system referred to above include processes for management activities, provision of resources, product realization, measurement, analysis and improvement.”
• In segment 4.2.1 “NOTE 3 The documentation can be in any form or type of medium."

There has been discussion in some circles about whether or not the standard should contain notes at all, or whether the standard requires that all notes be complied with. In fact some external auditors believe (wrongly) that these notes must be complied with.

ISO 9001 segment clarifies the use of notes. It states “Information marked “NOTE” is for guidance in understanding or clarifying the associated requirement."

When reading the standard, the key word that identifies a requirement which must be complied with is the word ‘shall’. In the standard, the word shall can be interpreted to mean the word ‘must’.

For example, in segment 4.2.3 Control of documents, the sentence “Documents required by the quality management system shall be controlled” can be interpreted to mean Documents required by the quality management system MUST be controlled in order to conform to the standard.

When reading through the standard, keep in mind the words shall and NOTE. Be sure to meet the requirements found to contain the word shall and use those sentences identified by the word NOTE for guidance and clarification only.

For questions or assistance with your ISO 9001 implementation visit www.rosehillsystems.com

The Management Representative

ISO 9001 section 5.5.2 states: "Top management shall appoint a member of the organization's management" [to oversee the quality management system(QMS)].  The responsibilities of the 'management representative' are:

• Assuring that the QMS is developed and the processes of the QMS are maintained
• Reporting to management on the performance of the QMS
• Promotion of awareness of customer requirements

In moderate and large sized organizations, this person is typically the individual responsible for the quality function, but this is not necessarily the case.  In smaller organizations , there may be no formal quality organization.  In this case any member of management who is prepared to take on the  responsibilities above can assume the position.  It is common for the selected individual to interface with customers and suppliers on quality matters.

For the management representative to be successful, he or she must have the support of top management, and must understand the ISO 9001 standard.  There are instances where decisions must be made about the acceptability of product.   Sometimes the correct decision is unpopular for cost or other reasons.  The management representative must be supported when difficult issues arise, and must be willing to make the right decision.

To implement the standard, it is common for the management representative to form a team.  A quality team should include one or more members of the following groups:

• Manufacturing
• Purchasing
• Engineering
• Sales

Other groups such as accounting, inventory management, and warehousing may also be possible contributors.

If the management representative is not a quality professional, he or she should receive training in ISO 9001, and have access to a quality assurance consultant.  The elements of the standard only cover 14 or so pages, but the wording is pithy.  An experienced quality professional will understand the wording and its interpretation in the context of business practice, but the representative inexperienced in quality will likely gloss over key points in the standard.

For assistance or more information visit www.rosehillsystems.com.

Quality Objectives

ISO 9001 segment 4.2.1 General states that the quality management system documentation must include documented statements of quality objectives.  It leaves it to management to determine what those objectives are.

Quality objectives should be in alignment with the quality policy, so it’s important to decide what the organization’s quality policy is.  For each QMS process, quality objectives should be established.  The objectives should be SMART.  That is Specific, Measurable, Achievable, Realistic and Timely.

For example, consider a quality policy that states:  ‘We will achieve zero defects in product shipped’.  If the organization is shipping 10% defective product, a SMART objective might be: ‘Achieve a 10% reduction in defects shipped in the next fiscal year’.  It doesn’t reach zero defects, but the objective heads in the direction the organization needs to go to achieve zero defects, so it is in alignment with its objective.

Each organizational unit that can affect the quality of the product should have metrics that show whether the department is meeting goals which drive the organization toward achieving its objectives.  Metrics should measure both efficiency and effectiveness. 

Efficiency measures the amount of resources consumed.  Effectiveness measures the success of the organizational unit in achieving its objectives.  In the example above, man-hours consumed to appraise product quality might be an efficiency metric.  Number of defective units shipped could be an effectiveness metric.  Achievement goals for each metric can be established and achieved within a period.  Achievement of these goals drives the organization toward the achievement of its objective.

I like to have at least one overall metric which tells the organization how it is doing.  For manufacturing operations a metric like first pass rejection rate, or warranty return rate are meaningful metrics. 

Consider measurements which can be quantified in dollars.  One organization I worked with had 20% late deliveries.  For that organization this represented $8 million in sales shipped late to customers.

I have provided some ideas to consider when establishing quality objectives.  An external auditor will view the organization’s metrics in the light of its objectives.  Establish SMART goals that are in alignment with the organization’s objectives, and be able to show that they are being achieved.

For more information visit www.rosehillsystems.com

 

Training Presentations

ISO 9001 Implementation requires that employees be trained in the standard.  Over the years I have done many training sessions in the standard.  These sessions typically take one to two days to conduct.  After a few hours going through the standard,  I find students eyes glossing over.   Either I or the material tends to put people to sleep.  In short I don't believe that a one or two day training session is particularly effective.

To address this training effectiveness issue, I have been developing PowerPoint presentations on specific elements of the standard.  The idea is that a segment can be covered completely in an hour or less, and can keep people's attention long enough to retain the material.  It also makes sense to train in an element as implementation of that element is about to start.

At www.rosehillsystems.com, in the Tools section, you will find a link these presentations.  They cover various elements of the standard with some added insight into implementation.  At this point there are a dozen or so presentations.  I will be adding to these presentations over time, so check back periodically.

Product Realization Planning

Product realization is the ISO 9001 term for product and / or service provision.  ISO 9001 section 7.1 states that: “The organization shall plan and develop the processes needed for product realization.”  A quality plan involves the following:

• Quality objectives
• Product requirements
• Documented processes
• Resources needed to produce, monitor and test the product
• Required verification, inspection, monitoring and measurement procedures
• Records needed to show that the processes and the resulting product meet requirements

Quality objectives should be consistent with the organization’s quality objectives.  Product requirements must be consistent with the outputs of the design process.

Documented production processes are not required, but it is a good idea to document how the processes that produce the product interact. A flow chart is a good way to show how the manufacturing of the product will occur and where the inspection points will be.  Documented inspection procedures which describe the product requirements, the inspection methods and tooling to be used, and the frequency of inspection assure a consistent inspection process.

Once the production processes are determined, it should be easy to determine the resources needed to create the product including:

• Manufacturing equipment
• Tooling
• Personnel needed to perform the work and do the inspection
• Inspection equipment and procedures
• Records needed

Inspection records are required.  The organization must be able to show that the product meets requirements, and the way to do this is to record inspection results.  Records should show the features inspected, the specification for each feature, the values obtained, the gauge / tool number used to perform the inspection, the inspector, and the date / time of inspection.  Inspection records can be a critical input to corrective actions, and analysis of data necessary for continual improvement.

For more information visit www.rosehillsystems.com

On-site Supplier Audits

In my recent post in March on Supplier Evaluations, I addressed supplier self-assessment questionnaires.  Questionnaires are good, but sometimes it is good to visit the customer.  What should one do when on-site at the supplier?

A client recently asked me how to conduct an on-site process audit of a supplier.  He was visiting the supplier anyway, so it made sense to him to conduct a process audit while there.

When doing such an audit, I like to start with known purchase orders (open and closed) and follow those orders from the point where the PO is received by the supplier to the point where the product ships.  Asking the supplier to retrieve records about a closed order also helps to assess the supplier’s record keeping.

To assist the client, I came up with 10 areas of questioning.   The questions follow a customer purchase order through the sales order, design, procurement, production and inspection processes.  They offer a pretty good idea about the supplier’s processes and how well aligned with the standard they are.  Such an audit can be conducted in a couple of hours and give a pretty good idea of the supplier’s compliance with ISO 9001 requirements.

You can find the questions here , in the advice section of my web site.  For questions, or additional information, visit www.rosehillsystems.com.

Training Requirements

ISO 9001 Section 6.2.2 Competence, training and awareness identifies five requirements:

1. Determine necessary competence
2. Provide training
3. Evaluate training given for effectiveness
4. Assure that personnel are aware of the relevance of their work
5. Maintain training records

1. Consider creating job descriptions. Job descriptions identify the skill set a qualified employee must possess to perform the functions of the job. Larger companies have them because they are used as a mechanism for determining the value of, and hence the wages paid for each job, but they also identify the training requirements for the employee.


2. With a job description in place, it is easy to do a gap analysis for an employee to determine what additional training he or she should be offered. Some training must be provided to all employees, and some training must be repeated periodically. Safety training is an example of training that in many cases is required to be given periodically. Most employees are not skilled in the requirements of ISO 9001, or quality in general, so some form of general quality training is normally required for all employees.


3. There are many ways to evaluate the effectiveness of training. One way is a periodic performance review. These are usually attached to pay increases, and, done properly; they also identify skills weaknesses that can be corrected by additional training. Perhaps the most effective method of determining training effectiveness is testing.


4. Employees want to do a good job. They know how to perform the tasks of the job and usually do it consistently well. But many manufacturing employees have no idea how what they are making or how the product they are making will be used. Explain to employees how the work they perform affects the quality of the products and services the organization supplies, and what the product does for the customer.
   
   Not explaining how the organization’s products are used can have unintended consequences. The Space Shuttle booster rockets were stored in a dry nitrogen environment prior to use. A component we produced helped circulate nitrogen in the storage container. We all watched the launch of the Challenger. When the Challenger space shuttle exploded on takeoff, the employee who assembled this component started crying because she believed that the product she produced had failed and caused the explosion. Of course this was not the case.


5. Each employee should have a training plan. A training plan outlines the training that a person is required to have. The training plan should be in alignment with the job description, and any other company or regulatory requirements for training. ISO 9001 requires that records of training performed be maintained. Training records can be compared to the required training and used to identify any required training which needs to be performed.

Finally, for those senior managers who believe that training is unnecessary, or a wasteful expense, I offer this question: How many incompetent people do you want working for you?

For more information visit www.rosehillsystems.com.  In the tools section you will find some PowerPoint presentations that can be used as a basis for ISO 9001 training.  Steal shamelessly.

Nonconforming Product

ISO 9001 section 8.3 Control of nonconforming product states: “The organization shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery.”  The standard requires that a specific procedure be written that describes how nonconforming product is controlled.

Simply put, the standard is saying: Don’t mix the good stuff with the bad stuff.  Defective material should be placed in an area specifically designated for nonconforming product.  That area should be segregated from good product and specifically labeled as nonconforming product.

The product placed in that area must be labeled, and its nonconformances identified.  It is common for organizations to generate a report that identifies and describes the defective product.  These reports go by many names such as Discrepant Material Report (DMR), Nonconformance Report (NCR), etc.  They typically identify the product, the discrepancy or discrepancies, and the number of pieces involved.  The form is also used to identify the actions taken, who authorized the actions, and what the final disposition of the material was.  The standard allows the following actions:

• Rework the product to specification
• Use as is (“authorizing its use, release or acceptance under concession”)
• Scrap
• Re-grade for some other purpose

My personal opinion is that ‘Use as is’ should be avoided if at all possible.  It has the following problems:

• An inferior product is gets shipped to customers
• A message is sent to employees that defects are acceptable

When product is reworked, it must be inspected for the defect originally identified. 

The discrepancy report, indicating the actions taken and the final disposition is a record which must be maintained.  Periodically records of nonconforming product should be analyzed.  Analysis might identify possible preventive actions that could reduce nonconformances in the future.

For more information visit www.rosehillsystems.com .

Supplier Evaluations

ISO 9001 section 7.4.1 states: “The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization’s requirements.  Criteria for selection, evaluation and re-evaluation shall be established.  Records of the results of evaluations … shall be maintained.”

Some customers use site visits to assess the capabilities of the supplier, but ISO 9001 does not specifically require this practice.  Most customers send potential suppliers a self-assessment questionnaire.  Self-assessment questionnaires can be simple or complicated to complete.  Be aware that the likelihood of receiving a response to a questionnaire is inversely proportional to the questionnaire’s complexity.

I’m not in favor of complicated multi-page questionnaires in most cases.  If the organization intends to place a small order with a supplier it is not likely to use often, it is unlikely that a complex questionnaire will be returned in a timely manner, if it is returned at all.  A simple, short questionnaire is more likely to be completed and returned.

If the supplier is to be a key supplier with a significant business opportunity, and a likely long term business arrangement, it may be better to visit the supplier and complete a complex questionnaire yourself in an on-site audit.  Meeting the players creates a better, more lasting relationship with the individuals involved.  These relationships make problem solving over the phone or by e-mail more likely to be successful.   As to what questions to ask, Govind Ramu presents an interesting perspective, in the Expert Answers section of   Quality Progress March, 2013 where he addresses questions to ask and not to ask a supplier.

Consider establishing (and documenting) multiple criteria any of which will qualify the supplier.  Examples might be:

·         ISO 9001 certified

·         Over one year experience with the supplier with few product rejections

·         Franchised supplier (for distributors)

As you collect supplier qualification data, consider storing the responses in a database.  The database facilitates contacting suppliers when quality problems arise and provides a tool for re-evaluating the supplier.  I recommend contacting the supplier near the time when his certification expires, and if it is not certified, annually.  A database can facilitate and automate this work.

Key suppliers, those suppliers who get most of your business, should be rated by some rating system routinely.  The ratings should be fed back to the supplier.  Examples of such ratings might be:

·         On time delivery percentage

·         Number of lots rejected divided by the number of lots received.

·         A multiple of the two above.

For an example of a simple questionnaire visit www.rosehillsystems.com and click on Tools.

Preventive Action

Preventive Action

Many get confused with corrective and preventive actions.  While corrective action deals with existing nonconformances (defects), preventive actions deal with nonconformities that haven’t occurred, but might occur in the future. 

In section 8.5.3 Preventive Action, ISO 9001 states “The organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence.”  Potential problems are usually identified from the analysis of metrics, or from audits.

For example, an organization has a metric for on time delivery, and will take corrective action when delivery falls below 95% on time.  The metric is above the limit, but examination of the metric chart shows that on time delivery has decreased each month for the past 5 months.  A corrective action is inappropriate because the metric hasn’t fallen below the requirement (95%).  In this case, preventive action is more appropriate.

Whereas corrective action requires that action be taken, preventive action does not.  Consider a control chart for a machine tool.  The chart indicates that the tool is wearing and may need to be replaced soon.  Do we change the tool now or wait until the control limit is exceeded?  An economic analysis might suggest that we wait for the control limit to be exceeded because the cost of the tool is high or the cost of lost production is high.   The customer may be in critical need of the product and we can’t afford to shut down the machine now.  A decision to continue production would close the preventive action.

 A decision to take action would allow the machine tool to continue operation while a plan is developed for implementing a replacement.  In contrast, if this were a corrective action, the tool would be shut down until a replacement is available.

Once the decision to take preventive action has been made, the process becomes very similar to corrective action.  An action is selected, usually by a team.  A plan is developed to implement the preventive action selected, and the implemented action is monitored for effectiveness.

Some organizations use one form for both preventive and corrective actions.  In the case of a preventive action, there is no evidence of nonconformance, and there is no containment plan, since a nonconformance has not occurred.  Root cause analysis still occurs because there may be many choices of actions to take.

When the action(s) have been identified, a plan for implementation is developed.

My steps of preventive action look like this:

1.       Problem statement

a.       State the requirement

b.      State the evidence of potential nonconformance

2.       Root cause analysis

3.       Preventive action plan

a.       What action(s) will be taken?  NOTE: The plan might be to do nothing.

b.      When will they be implemented?

4.       Follow Up

a.       Were the actions taken effective?

In contrast, my 5 steps of corrective (See my August 2012 blog) are

1.       Problem Statement

a.       State the requirement

b.      State the nonconformance

c.       State the objective evidence of the nonconformance

2.       Containment Plan

a.       When did the problem start?

b.      What are we doing to control the bleeding while we are looking for a solution ( short term fix)

3.       Root Cause Analysis

4.       Corrective Action Plan

a.       What will be done to eliminate the root cause(s)?

b.      When will they be implemented?

5.       Follow Up

a.       Was the implemented corrective action effective?

b.      Was the short term fix removed?

 

For more information visit www.rosehillsystems.com

Production Control

ISO 9001 section 7.5.1 states:  “The organization shall plan and carry out production and service provision under controlled conditions.”  It goes on to state that controlled conditions means availability of product specifications, work instructions, equipment, and test equipment etc.

In an audit I was conducting recently, I came across a work instruction that instructed the technician to ‘use the custom jig.’  This raises the question:  Does ‘controlled conditions’ mean that jigs and fixtures should be identified and controlled?  It’s an important question from the auditor’s point of view.  If the fixtures are not controlled, should I write a corrective action?

To me, control means the same thing for a tool that it means for a document or  inspection equipment.   It should be identified, it should have a revision, changes to it should be approved prior to issue, and it should be inspected periodically to assure it is viable for use.

I raised the question of controlled tools with other quality professionals, and they all seemed to think the standard is moot on this point.  They all agreed that it makes prudent sense though.  Other standards such as AS9100 (the aerospace equivalent of ISO 9001) clearly state the requirement for tool and jig control.

Consider the potential problems:

·         A fixture used in production wears out over time and must be replaced.  Without a drawing, how do we make a new one that works the same as the last one?

·       The fabricator of the fixture leaves the company, or worse, we need to use the tribal knowledge of the person who made it to make another (assuming he or she remembers how).

·         A technician trainee doesn’t know what ‘use the custom jig’ means and doesn’t use the one we’ve fabricated for the purpose.

The standard leaves many things to interpretation by the external auditor.  Regardless of what the standard says, or how it is interpreted, be sure to document all production tooling with a tool number or other identifier, revision level, and a controlled drawing.  Inspect the tooling periodically to assure it has not worn to the point where it should be replaced.  It may make your ISO 9001 implementation a little easier.

For more information go to www.rosehillsystems.com

On Inspection

ISO 9001 section 8.2.4 states “The organization shall monitor and measure the characteristics of the product to verify that product requirements have been met.”   The standard goes on to say “Evidence of conformity with the acceptance criteria shall be maintained.”  It fails to point out though that quality cannot be inspected into the product.

Many organizations fail to achieve high quality, because they rely on inspection in the belief that they can inspect quality into the product.  Point 3 of Edward Deming’s 14 points states “Cease dependence on inspection to achieve quality.  Eliminate the need for inspection on a mass basis by building quality into the product in the first place.”  Phillip Crosby’s second absolute of quality says it differently: “The way to cause quality is through prevention not appraisal [inspection]”.

For a good example of what can happen when inspection is used as the only means of assuring quality read Austin, A L (2013) “Failure of Inspection The consequences of layering on quality checks” Quality Progress, January 2013.

In an audit I performed recently, the customer was inspecting welds using dye penetrant testing.  I issued a corrective action because no evidence that the tests had been performed was available.  The test reports didn’t include a place for the technician to indicate that the testing had been performed.  When inspection is performed assure that the results of inspection are recorded. 

Keep in mind that even 100% inspection is not 100% effective.  Inspectors make mistakes too.  Focus on mistake proofing production processes and designing quality into the product, not inspecting quality into the product.  Inspect when you must.  Select inspection points to occur just before high cost processes occur.  This assures that the product conforms to requirements before high cost is added to the product.  When you inspect assure that the results of inspection are recorded.

For more information go to www.rosehillsystems.com